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Parliamentary questions
12 May 2017
E-001508/2017
Answer given by Mr Andriukaitis on behalf of the Commission

The Commission is ready to support Member States and the European Medicines Agency to tackle the problem of shortages of medicines which can have serious consequences on the health of patients(1). Some work is already being undertaken by the national authorities, who meet regularly through the Heads of Medicines Agencies network(2).

On 27 March 2017, the Commission also raised the issue of shortages within the Commission's expert Committee on Pharmaceuticals and some Member States expressed interest to follow-up on the recommendations laid down in the recent own initiative report of the European Parliament on access to medicines.

The Commission has no further means to help with the treatments of patients in Romania, as measures regulating the organisation of the health systems and the delivery of care are Member States' responsibility. The Member States are also responsible for ensuring the marketing authorisation holders and wholesale distributors' obligations of continuous supply of medicines to cover the needs of patients.

Moreover, a Member State can authorise the placing on the market of a medicine from another Member State or use an unauthorised medicine for the treatment of patients(3).

In addition, Member States may adopt certain restrictions on parallel trade subject to ensuring compliance with the Treaty provisions. It should be noted that some Member States have already taken national measures to prevent shortages of medicines arising from parallel trade.

(1)http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000588.jsp&mid=WC0b01ac05807477a5
(2)http://www.hma.eu/abouthma.html?&L=0
(3)http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32001L0083&from=en

Last updated: 18 May 2017Legal notice